BEUDAMED
    FDA Adverse Event Summary report: N

    HICKMAN 7 FR DUAL-LUMEN CV CATHETER

    MDR report key: 4131199 · Received August 15, 2014

    Report

    Report Number
    3006260740-2014-00419
    Date Received
    August 15, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 18, 2014
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    PMA / PMN Number
    K830233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER AT THIS TIME FOR EVAL. A LOT HISTORY REVIEW (LHR) OF HUYC1139 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    (B)(6) 2014, A (B)(6) YR OLD C/O DISCOMFORT/PAIN AT HICKMAN 7FR TUNNELED DOUBLE LUMEN CATHETER SITE, FELT "POP" WHEN FLUSHED. TPN INFUSION STOPPED. CHEST X-RAY DONE. PT TO IR. CONTRAST INJECTED AND DETERMINED CATHETER WAS FRACTURED JUST ABOVE BIFURCATION. CATHETER REMOVED AND NEW DOUBLE LUMEN LINE INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491730 HICKMAN 7 FR DUAL-LUMEN CV CATHETER LJS BARD ACCESS SYSTEMS HUYC1139

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention